Teligent, Inc. Announces FDA Approval For Three Abbreviated New Drug Applications

BUENA, N.J., Jan. 3, 2017 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of three of the Company's abbreviated new drug applications (ANDAs) from the U.S. Food and Drug Administration (FDA) of Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram and 1 mg/gram, Clindamycin Phosphate Topical Solution USP, 1% and Flurandrenolide Ointment USP, 0.05%.  These approvals were received on December 30, 2016 and brings Teligent's total approvals from its internally developed pipeline of topical generic pharmaceutical products in 2016 to nine.

Based on recent IMS Health data from November 2016, the total addressable market for these three products is approximately $73.6 million.

"Teligent received FDA approval for all three of these ANDAs on the last day of 2016, which marks a tremendous completion to a strong year for our team,'' commented Jason Grenfell-Gardner, President and CEO of the Company. "In addition, our partner received approval for Flurandrenolide Lotion USP, 0.05%, a product we developed and submitted for them and we anticipate manufacturing that product for our partner in the coming weeks. We now have twenty FDA-approved specialty generic prescription drug products in our domestic portfolio, evidencing the continued successful implementation of our development and diversification strategy. Just one year ago, our total domestic portfolio was only eleven products. Our commercialization team expects to launch all three of our new products in the first quarter of 2017."

About Teligent, Inc.

Teligent is a specialty generic pharmaceutical company. Our mission is to be a leading player in the specialty generic prescription drug market. Learn more on our website www.teligent.com.

Forward-Looking Statements

This press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions, and other statements contained in this press release that are not historical facts and statements identified by words such as "plan," "believe," "continue," "should" or words of similar meaning. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: our inability to meet current or future regulatory requirements in connection with existing or future ANDAs; our inability to achieve profitability; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy; the potential lack of market acceptance of our products; our inability to protect our intellectual property rights; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete successfully future product acquisitions. These statements are based on our current beliefs or expectations and are inherently subject to various risks and uncertainties, including those set forth under the caption "Risk Factors" in Teligent, Inc.'s most recent Annual Report on Form 10-K,  Quarterly Reports on Form 10-Q and other periodic reports we file with the Securities and Exchange Commission. Teligent, Inc. does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.

Contact:
Jenniffer Collins
Teligent, Inc.
(856) 697-4379
www.teligent.com

SOURCE Teligent, Inc.

Related Links

http://www.teligent.com